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Single-Ascending Dose Study of AMG 333 in Healthy Subjects and Subjects With Migraines

NCT ID: NCT01953341

Last Updated: 2014-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2014-11-30

Brief Summary

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The primary purpose of this study is to determine whether AMG 333 is safe and well tolerated in healthy subjects and subjects with migraines. As part of the secondary objectives, this study will characterize the pharmacokinetic (PK) profile of AMG 333, as well as characterize the effect of AMG 333 on the cold pressor test (CPT)-induced increase in blood pressure after single oral doses in healthy subjects and subjects with migraines

Detailed Description

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This is a randomized, double-blind, placebo-controlled, ascending single-dose study evaluating AMG 333 in healthy subjects and subjects with migraines. The study will consist of 8 cohorts: 7 cohorts of healthy subjects and 1 cohort of subjects with migraines. For cohorts 1 to 7, 8 subjects each will be enrolled, and subjects will be randomized such that 6 subjects will receive AMG 333 and 2 subjects will receive placebo (3:1 ratio). In cohort 8, up to 24 subjects with migraines will be enrolled, depending on enrollment rate and emerging safety and tolerability data. These migraine subjects will be randomized to receive AMG 333 or placebo in a crossover fashion. Both healthy and migraine subjects will be monitored in house for 4 days then allowed to return home for the remainder of the 14 day observation period. Both healthy and migraine subjects will keep headache diaries.

Conditions

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Migraine

Keywords

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Migraine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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AMG 333

Subjects will receive a single oral dose of AMG 333 .

Group Type EXPERIMENTAL

AMG 333

Intervention Type DRUG

Oral administration available in varying dose strength.

Placebo

Subjects will receive a single oral dose of placebo.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo containing no active drug

Interventions

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AMG 333

Oral administration available in varying dose strength.

Intervention Type DRUG

Placebo

Placebo containing no active drug

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male and female subjects with or without migraines ≥18 and ≤55 years of age at the time of screening, with no history or evidence of clinically relevant medical disorders as determined by the investigator in consultation with the Amgen physician.

Exclusion Criteria

* History or evidence of a clinically significant disorder, condition, or disease that, in the opinion of the investigator and Amgen physician, would significantly impair pain perception (eg, history of stroke, history of neuropathy) or interfere with evaluation, procedures, or study completion.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Amgen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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MD

Role: STUDY_DIRECTOR

Amgen

Locations

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Research Site

Salt Lake City, Utah, United States

Site Status

Countries

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United States

Related Links

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http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

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20130102

Identifier Type: -

Identifier Source: org_study_id